We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies.

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Not so NICE for Avastin

30 Jun 2008

News

Executive Summary

The U.K.'s National Institute for Health and Clinical Excellence terminates its review of Roche/Genentech's Avastin (bevacizumab) for first-line metastatic breast cancer because the sponsor failed to submit sufficient evidence, the regulatory body announces June 25. Avastin received approval for a breast cancer indication in the U.S. in February. NICE also stopped its review of Avastin for the first-line treatment of metastatic or recurrent non-small cell lung cancer, another indication approved in the U.S. Review of Bristol-Myers Squibb/ImClone/Merck KGaA's Erbitux (cetuximab) for second-line treatment of colorectal cancer was similarly terminated due to the failure to submit sufficient evidence

You may also be interested in...

In a statement submitted to the Senate Finance Committee, Natural Products Association CEO Dan Fabricant suggests two ways of improving compliance with new dietary ingredient notification requirements at negligible expense to the US FDA.

US FDA investigators are more likely to cite cell and gene therapy manufacturers for facilities and production deficiencies, agency says, while industry reports difficulties complying with drug GMP requirements that are not always applicable to cell and gene therapies.